BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1871900 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17423
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    July 23, 2010
    Report Date
    August 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE STEROID COLLAR WAS MISSING. MEDICAL ADHESIVE WAS OBSERVED AT THE BONDING LOCATION. NO DAMAGE TO THE HELIX WAS NOTED. THE MANNITOL COATING WAS NOT PRESENT DURING ANALYSIS. ANALYSIS WAS UNABLE TO CONFIRM WHETHER EXCESSIVE FORCES APPLIED TO THE TIP CONTRIBUTED TO THE BROKEN STEROID COLLAR.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT, DURING REMOVAL OF THIS LEAD FROM PACKAGING PRIOR TO AN IMPLANT PROCEDURE, THE STEROID COLLAR BROKE OFF IN SEVERAL PIECES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1